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Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers (DLR Pilot)

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University of Rochester

Status

Completed

Conditions

Cognitive Impairment, Mild
Cancer, Advanced

Treatments

Behavioral: Dyadic Life Review (DLR)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05200572
P30AG064103 (U.S. NIH Grant/Contract)
T32CA102618 (U.S. NIH Grant/Contract)
STUDY00006662

Details and patient eligibility

About

The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with patients and caregivers of older adults with advanced cancer, including those with also Mild Cognitive Impairment (MCI). The study will enroll aim to enroll 20 dyads (pairs) of patients and caregivers (40 total subjects).

Enrollment

38 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

  • Age ≥ 65
  • Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score >14.5 will define ability to independently provide informed consent.
  • Eligible patients have Stage III or IV cancer of any type
  • Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of <26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.
  • Able to read and understand English

Patient Exclusion Criteria:

  • Patients scoring <14.5 on the UBACC
  • Unable to identify caregiver to participate in study

Caregiver Inclusion Criteria:

  • One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
  • Caregivers will be selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
  • Age 50 or older
  • Ability to provide consent
  • Proficient in English

Caregiver Exclusion Criteria

  • Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Total subjects
Experimental group
Description:
We will enroll dyads (defined as a pair of two people). The dyads are made up of a patient with cancer and their caregiver. The patient and caregiver dyad will go through the Dyadic Life Review intervention together. Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Both patients and caregivers will each complete their own measures before and after completing the Dyadic Life Review intervention.
Treatment:
Behavioral: Dyadic Life Review (DLR)

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Lee Kehoe, PhD; Lauren Mitchell

Data sourced from clinicaltrials.gov

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